Real-World Evidence Analysis of a Hybrid Closed-Loop System.
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BORIS DOI
Publisher DOI
PubMed ID
37421250
Description
BACKGROUND
We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system.
METHODS
Users from 15 countries across different age groups who used the system between May 9, 2022, and December 3, 2022, and who had ≥30 days of continuous glucose monitor data, and ≥30% of closed-loop usage were included in the current analysis (N = 1805).
RESULTS
Time in range (3.9-10 mmol/L) was 72.6 ± 11.5% (mean ± SD) for all users and increased by age from 66.9 ± 11.7% for users ≤6 years old to 81.8 ± 8.7% for users ≥65 years. Time spent in hypoglycemia (<3.9 mmol/L) was 2.3% [1.3, 3.6] (median [interquartile range]). Mean glucose and glucose management indicator were 8.4 ± 1.1 mmol/L and 6.9%, respectively. Time using closed-loop was high at 94.7% [90.0, 96.9].
CONCLUSIONS
Glycemic outcomes from the present real-world evidence are comparable to results obtained from previous randomized controlled studies and confirm the efficacy of this hybrid closed-loop system in real-world settings.
We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system.
METHODS
Users from 15 countries across different age groups who used the system between May 9, 2022, and December 3, 2022, and who had ≥30 days of continuous glucose monitor data, and ≥30% of closed-loop usage were included in the current analysis (N = 1805).
RESULTS
Time in range (3.9-10 mmol/L) was 72.6 ± 11.5% (mean ± SD) for all users and increased by age from 66.9 ± 11.7% for users ≤6 years old to 81.8 ± 8.7% for users ≥65 years. Time spent in hypoglycemia (<3.9 mmol/L) was 2.3% [1.3, 3.6] (median [interquartile range]). Mean glucose and glucose management indicator were 8.4 ± 1.1 mmol/L and 6.9%, respectively. Time using closed-loop was high at 94.7% [90.0, 96.9].
CONCLUSIONS
Glycemic outcomes from the present real-world evidence are comparable to results obtained from previous randomized controlled studies and confirm the efficacy of this hybrid closed-loop system in real-world settings.
Date of Publication
2025-03
Publication Type
Article
Keyword(s)
artificial pancreas closed-loop systems real-world evidence type 1 diabetes
Language(s)
en
Contributor(s)
Wilinska, Malgorzata E | |
Ruan, Yue | |
Da Silva, Julien | |
Hovorka, Roman |
Additional Credits
Series
Journal of Diabetes Science and Technology
Publisher
SAGE Publications
ISSN
1932-2968
Access(Rights)
open.access